Press Releases

Congressman Larry Bucshon (IN-08) released the following comment praising the bipartisan passage of the Food & Drug Administration Reform Act of 2012 by unanimous consent through a voice vote.  The legislation includes important components of the bipartisan Drug Shortage Prevention Act (H.R. 3839) introduced by Congressman John Carney (D-DE) and Congressman Bucshon.

Congressman Bucshon (IN-08) states:

            “Final passage of the Food and Drug Administration Reform Act is a positive sign that the House and Senate can work together in a bipartisan manner when the best interests of citizens are put first.  It is personally pleasing to me to see provisions of the bipartisan Drug Shortage Prevention Act included.  This bipartisan bill I introduced with Congressman John Carney will aid patients in obtaining critical medicines.  As a physician, I am confident this legislation will maintain our nation’s role as the world leader in medical innovation.”

Background:

A number of key provisions from the Drug Shortage Prevention Act are included in the legislation, including:

Actions by Attorney General to Address Critical Drug Shortages

• If a drug on the critical drug shortage list contains or is a controlled substance subject to a quota, the Attorney General is directed to increase the quota, in consultation with the Secretary of Health and Human Services, to address the critical drug shortage.

FDA Drug Approval Process

• The Secretary shall expedite the review of any application seeking approval of a critical drug and any request by a manufacturer of a critical drug to approve a change to the manufacturing process or facilities of that drug in order to mitigate or prevent a shortage.

Improved Regulation of Critical Drugs

Requires strategic plan to ensure that:

• Ensure that, at each stage of the regulatory process, the status of drugs as critical drugs is taken into consideration
• Improve communications between offices within FDA responsible for approving and regulating critical drugs and offices of FDA responsible for identifying and addressing critical drug shortages
• Ensure that FDA communicates any new regulatory concern identified by FDA about a critical drug to the office within FDA responsible for identifying and addressing critical drug shortages

National Critical Drug Shortage List

• The Secretary must establish a publically available list identifying each critical drug shortage
• At a minimum, the list must include access to the following information:
  • Each reason for the shortage
  • Estimated date by which drugs will begin reaching providers in a quantity sufficient to meet demand

Congressman Bucshon and Congressman Carney are members of a Bipartisan Working Group that regularly meets to discuss issues of importance.  The Drug Shortage Prevention Act was developed due to their participation.

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